Molding and packaging articles substantially free from contaminants

ABSTRACT

An apparatus and method are provided for manufacturing articles, such as syringe barrels, substantially free from contaminants. The apparatus is an enclosure defining at least a class 100 and MCB-3 environment, and includes a molding isolation module and a packaging isolation module. Any contaminants that may exist within the enclosure are removed by the use of horizontal and vertical laminar airflows directed into air filter units. Further, the molding temperature may be selected such that it renders the fabricated articles substantially free from contaminants. The molding isolation module and packaging isolation module keep the fabricated articles substantially free from contaminants from the time the articles are molded to the time the articles are placed in sealed containers for shipment.

This application is a division of application Ser. No. 08/518,027 filedAug. 22, 1995 now U.S. Pat. No. 5,687,542.

TECHNICAL FIELD OF INVENTION

This invention relates in general to manufacturing articlessubstantially free from contaminants, and more particularly relates toapparatus and methods for molding and packaging articles, such assyringe barrels, in a molding and packaging isolation module,substantially free from contaminants.

BACKGROUND OF THE INVENTION

Manufacturing processes for prefilled syringes are known in the art. Forexample, processes are known for producing prefilled, sterile glasssyringes whereby the manufactured syringe components are washed andsterilized prior to partial assembly. The partially assembled glasssyringe is filled with a fluid, sealed with a plunger, and sterilizedonce again by heating. U.S. Pat. Nos. 4,718,463 and 4,628,969, bothissued to Jurgens, Jr. et al., teach a process for manufacturingplastic, prefilled syringes using repeated water jet washing of thesyringe components prior to assembly and filling. Water washing isexpensive because it requires ultra-purified water. Water washing isalso troublesome because it is difficult to inspect and ensuresatisfactory cleaning. Therefore, it is desirable to reduce the numberof washing steps required in the manufacture of prefilled syringes.Further, prior art syringe manufacturing processes do not provideprecautionary steps to maintain syringe components substantially freefrom contaminants, such as viable and nonviable particles, duringmolding, assembly and filling. Therefore, it is desirable to develop amethod for manufacturing prefilled syringes which substantially reducesviable and nonviable particles that may contaminate the syringecomponents during molding, assembly and filling.

SUMMARY OF THE INVENTION

The present invention provides an apparatus and method for manufacturingarticles, such as syringe barrels, substantially free from contaminants,such as viable and non-viable particles. In a preferred embodiment, theapparatus includes a molding isolation module and a packaging isolationmodule located within an enclosure, preferably defining a class 100environment and a class MCB-3 environment. A class 100 environment, asused herein, is defined as an environment having no more than 100 viableor nonviable particles per cubic foot of air, 0.5 microns and larger. AMCB-3 environment, as used herein, is defined as an environment whereinthe microbial level of gram positive microorganisms is less than 3 cfu(colony forming unit) per cubic foot of air, and the microbial level ofgram negative microorganisms is less than 1 cfu per cubic foot of air.

In a preferred embodiment, the molding process is used within themolding isolation module generates enough heat to render the moldedarticles substantially free from contaminants. Thereafter, anycontaminants generated inside or outside the enclosure is diverted byair flow in such a way that the articles remain substantially clean. Inanother preferred embodiment, the molding isolation module contains agas which sterilizes and maintains the cleanliness of the moldedarticles. In the preferred embodiments, airborne contaminants are sweptthrough air filters and out of the enclosure at a sufficient speed thatthe airflow inside the enclosure is laminar. In one area of theenclosure, where preferably no humans are employed, the airflow isarranged to be horizontal. In those areas of the enclosure to whichhuman personnel have access, the airflow is vertical.

The molded articles are created using a typical injection moldingprocess. The material flows through injection gates to mold platenslocated within the molding isolation module. A robot or mechanical armwithin the molding isolation module retrieves the molded articles fromthe platens and places them on a conveyor. The robot workspace has ahorizontal laminar airflow with the air being drawn from outside themolding isolation module through a high-efficiency particulate air(HEPA) filter. This air is subsequently dumped to the outside of themolding isolation module, carrying with it any contaminants generatedwithin the molding isolation module. The laminar nature of the airflowminimizes the settling of contaminants on the articles.

The conveyor leads to an inspection station within the packagingisolation module, manned by a human worker, where the articles areinspected. Preferably, the articles are placed into a class 100 moldedholder at this step. A laminar airflow at this stage proceeds verticallytop down and is circulated through a HEPA filter.

The articles are passed to a packaging station within the packagingisolation module at which the articles are packaged within containersthemselves substantially free from contaminants. Packaging supplies arekept within the packaging isolation module.

While the process and enclosure are described herein with respect tosyringe barrels, they have application to any article, container orcomponent which is molded using a heated process, where it is desiredthat such article be maintained substantially free from contaminants.Thus, other syringe components, other parts for medical use or otherarticles which must be substantially free from contaminants can bemanufactured using the apparatus and process of the invention. Asapplied to syringes, the process could be modified to include fillingand assembly steps to complete the assembly and packaging of prefilledsyringes ready for use.

The present invention confers a technical advantage in that cumbersomeand expensive decontamination apparatus, such as washing apparatus isnot required. Instead, a relatively simple enclosure, fans or other airforcing apparatus, and filters are employed. The maintenance ofcleanliness is made more human-friendly as there is a decrease inpossibility of exposure to dangerous temperatures or chemicals. Finally,the present invention is energy-efficient in that the same heat sourceused to mold the articles is used to render the articles substantiallyfree from contaminants.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic plan view of a first embodiment of the inventionshowing the mold platens of the molding module in a closed position;

FIG. 2 is a schematic plan view of a second embodiment of the inventionshowing the mold platens of the molding module in an open position;

FIGS. 3a and 3b are isometric views of a portion of the molding moduleaccording to the invention showing the mold platens in a closed and openposition, respectively;

FIG. 4 is a front elevational view of the enclosure of FIG. 2 showingtop-to-bottom laminar airflow with arrows;

FIGS. 5a and 5b are isometric views of a packaging isolation module ofthe invention having open access slots and glove ports, respectively;

FIG. 6 is a schematic diagram showing successive steps in a packagingprocess according to the invention; and

FIG. 7 is a schematic plan of coupled isolation modules used whenarticles are manufactured in different molds and assembled while stillisolated from contaminants.

DETAILED DESCRIPTION

A first embodiment of the article molding and packaging enclosure 10 ofthe invention is shown in FIG. 1. Enclosure 10 defines an environmentsubstantially free from contaminants, such as viable and non-viableparticles. In a preferred embodiment, enclosure 10 defines at least aclass 100 environment and at least a MCB-3 environment. Enclosure 10includes two main components, a molding isolation module indicatedgenerally at 12, and a packaging isolation module indicated generally at14. Enclosure 10 is preferably fabricated using stainless steel panelsand tubes to form a plurality of sidewalls 16, and is preferably oncastors (not shown) which permit movement of the enclosure 10 whenunlocked and which remain stationary when locked.

An injection molding machine 18 connected to the molding isolationmodule 12 is filled with a material from which articles are to bemolded. In a preferred embodiment, the material is plastic pellets usedto manufacture syringe barrels. The injection molding machine 18 isbasically a tube with a screw conveyor and heating elements (not shown)disposed around the tube. A front end 20 of the injection moldingmachine 18 communicates with the interior of a first mold platen 22located within the molding isolation module 12. The mold platen 22 and acorresponding mating mold platen 24 (also located within the moldingisolation module 12) together form a mold for a plurality of articles tobe fabricated, such as syringe barrels. The mold platens 22 and 24 alsoare supplied with heating wires 80 and cooling tubes 82, as shown inFIGS. 3a and 3b, and more fully described below.

While the illustrated embodiments of the invention employ a moldingprocess in which electric heat is used to melt thermoplastic pellets,the invention is not limited to thermoplastic processes or even toorganic materials. The invention has application to any fabricationprocess which generates enough heat to render the articles fabricatedsubstantially free from contaminants. For example, the process can beused in conjunction with articles made of thermosetting polymers, glass,ceramics or even metals. The invention also has application to processeswhere the temperature is not high enough to render the fabricatedarticle substantially free from contaminants, but where it is desirableto keep the articles substantially free from contaminates by usingsterilizing gas in the molding isolation module 12.

As shown in FIG. 1, the mold platens 22 and 24 in their closed position,occupy a terminal end of the molding isolation module 12. Mold platen 24is connected via a vertical hinge 26 to a stainless steel panel 28,which in turn is connected by a vertical hinge 30 to a further stainlesssteel panel 32. Mold platen 22 is connected to side wall 36 and theinjection molding machine 18, and remains fixed during operation.Plastic is injected into mold platens 22 and 24 while the mold platens22 and 24 are in a closed position. After the articles have cooledsufficiently, mold platen 24 is moved away from mold platen 22. Hinges26 and 30 end and plate 28 shortens to allow platen 24 to move. Plate 28is made from two pieces of overlapping material, with a sliding seal,for example, commercially available Teflon®, to prevent air leakage. Thetop and bottom edges of plate 28 also have a sliding seal to the top andbottom of the molding isolation module 12. An end sidewall 42 of themolding isolation module 12 includes an exhaust opening in adjacency tothe platens 22 and 24.

A robot (not shown) moves about inside of a work envelope within themolding isolation module 12 represented by the dashed rectangle 46.Alternatively, the robot may be replaced with a mechanical arm (notshown) which is capable of traversing the work envelope 46. When themold platens 22 and 24 are opened, as shown in FIG. 2, the robot picksor retrieves the molded articles, such as syringe barrels out of themold, travels down to the other end of the molding isolation module 12,and deposits the molded articles on a circular carousel 48. The moldedsyringe barrels or other articles travel on the carousel 48 whichrotates around to the packaging isolation module 14 for furtherprocessing.

In one embodiment of the invention, the injection molding machine 18 andthe mold platens 22 and 24 generate sufficient heat to render the meltedplastic being molded therein, substantially free from contaminants,thus, avoiding the necessity for decontaminating the molded articles byany suitable means such as autoclaving, or ultrasonic or repeated jetwashing with ultra-purified water or freon. The only contaminant sourceis external to the articles themselves.

To keep contaminants from settling on the molded articles, a preferablyhorizontal, laminar airflow is set up inside the molding isolationmodule 12. Enclosure 10 is preferably placed inside of a class 100,000environment defined herein as an environment having no more than 100,000viable or nonviable particles per cubic foot of air, 0.5 microns andlarger. The direction of air flow within the molding isolation module 12is from the end containing the carousel 48 to the end at which aredisposed platens 22 and 24, as shown by the dashed arrows.

In a preferred embodiment, the air source at the end of the isolationmodule 12 is a HEPA (high efficiency particle arresting) unit positionedat 50. The HEPA filter unit 50 draws in air from the surrounding class100,000 environment, filters it and blows the air in horizontal laminarfashion down the mold isolation module 12 toward the platens 22 and 24.The HEPA filter 50 includes an independent blower, preferably having acapacity of at least 4,000 cubic feet per minute (cfm) at 500 feet perminute (fpm). Alternatively, filter 50 may be an ultra low penetrationair (ULPA) filter.

The HEPA unit 50 must develop sufficient velocity and volume to fullyenvelop the molded articles when the mold platens 22 and 24 are open, asshown in FIG. 2, and when the articles are transferred to the packagingisolation module 14. At a minimum, the airflow proximate the platens 22and 24 should have a velocity of 100 fpm, a throughput 1400 cfm and behorizontally laminar. All HEPA filters employed should be at least99.97% efficient. The entire enclosure 10 should operate at a positiveminimum 0.5" w.c. pressure relative to the ambient pressure of the class100,000 environment in which the enclosure 10 is placed. Baffles orpartitions (not shown) having a minimum opening area separate theairflow in the molding isolation module 12 from the packaging isolationmodule 14 (i.e. a slotted window, for the operator to reach thearticles). As shown in FIG. 1, carousel 48 carries the articles from themolding isolation module 12 to the packaging isolation module 14, andthe operator does not need to reach into the molding isolation module12.

In a preferred embodiment of the invention, as shown in FIG. 1, thepackaging isolation module 14 includes two stations manned by humanpersonnel, an inspection station indicated generally at 52 and apackaging station indicated generally at 54. Stations 52 and 54 arepartially enclosed by sidewalls, but have either access slots or glovedports, as more fully described below, to permit access by the hands andarms of an inspector 56 and a packager 58. The range of arm reach of theinspector 56 and of the packager 58 are indicated by dotted arcs 60 and62.

The carousel 48 includes a curb 64 such that a plurality of moldedarticles can accumulate against it. The articles, such as syringebarrels, are picked up by the inspector 56 and inspected for defects.Any runners, scrap and rejects from the injection molding process aredisposed of in a waste bin 66 adjacent, or underneath, a syringe barrelaccumulator (not shown).

A plurality of barrel holders, such as the ones shown at 68, each holdfour different syringe barrels and are sourced at a barrel holdermagazine 70 which is located adjacent the carousel 48. The holders 68had been made previously in this or a similar enclosure, and packaged inat least class 100 conditions. The holders 68 are placed in a horizontalrail 72 to facilitate insertion of the barrels. The rail 72 alsofacilitates transfer of each barrel holder 68 to the packaging station54 after the barrels (not shown) have been inserted. The packager 58inserts two linked clips 68 of barrels, for a total of 8 barrels, into afirst container, such as a plastic bag. Further packaging steps arediscussed below in conjunction with FIG. 6. The airflow inside thepackaging module 14 is vertical from top to bottom, as discussed belowin conjunction with FIG. 4.

FIG. 2 illustrates another embodiment of the invention in which thecarousel 48 has been replaced with a conveyor 74. Otherwise, likeelements are identified by like characters in FIGS. 1 and 2. In FIG. 2,the mold platens 22 and 24 are shown in an open position, permitting thehorizontal laminar airflow shown by dashed arrows to go between theplatens 22 and 24.

The articulation of platens 22 and 24 between the open and closedpositions is more particularly illustrated by the isometric, schematicdiagrams shown in FIGS. 3a and 3b. FIG. 3a corresponds to the positionsof platens 22 and 24 as shown in FIG. 1. In this position, the platens22 and 24 are forced together by any suitable mechanism, such as ahydraulic or motor-driven apparatus (not shown), blocking off directaccess to the exhaust opening in sidewall 42. Platen 22 has affixed intoits front end a baffle 76, indicated in FIGS. 3a and 3b in phantom,which has a curved surface that curves downwardly from a forward,horizontal position to a rearward, vertical position. Platen 24 has abaffle 78 that is similar in shape to baffle 76 and which, when theplatens 22 and 24 are moved together, forms a continuous surfacetherewith. The baffles 76 and 78 act to redirect the horizontal laminarairflow downwardly through appropriate ductwork in the floor, indicatedschematically by the arrows 79. This duct work leads to the exhaust intothe class 100,000 environment.

FIG. 3b illustrates the condition of the platens 22 and 24 after aninjection molding and cooling operation has been completed. The platens22 and 24 are separated from each other in the center, permitting thehorizontal laminar airflow to pass between them into the exhaust openingin end wall 42 shown in FIGS. 1 and 2. As separated, the baffles 76 and78 no longer redirect all of the airflow. Some of the air continueshorizontally over the platens 22 and 24, maintaining cleanliness of themolded articles. Each platen 22 and 24 is equipped with heating wires 80for electrical heating current and cooling tubes 82 for the circulationof cooling fluid in order to control the temperature in platens 22 and24. A top, trapezoidal stainless steel panel 84 prevents escape of thefiltered air into the class 100,000 environment.

Returning to FIG. 2, the embodiment illustrated therein also differsfrom the embodiment shown in FIG. 1 in providing an accurately curvedfront sidewall 85 to allow the forward positioning of the inspector 56and to give him or her a concomitantly greater reach. The packagingstation 54 is equipped with a turntable 86, indicated in dotted line inFIG. 2, and a bag sealing device 88 positioned immediately in front ofthe packager 58. The packaging station 54 is also provided withpackaging supplies including first containers 90, such as plastic bags,and second containers 92, such as plastic bags, and labels 94, allcontained in respective receptacles. The packaging supplies are used topreserve the cleanliness of the articles as they leave the enclosure andare transported to a different work area.

A schematic elevational side view of the enclosure 10 shown in FIG. 2 isillustrated in FIG. 4. The molding isolation module 12 is provided witha robot superstructure clear area 96 which is located above amolding/transfer volume 98. In the embodiment illustrated in FIG. 4, therobot (not shown) is suspended on an arm 100, which in turn is suspendedfrom a channel 102 affixed inside of the robot clear area 96. Astainless steel panel 104 between the robot rail 102 and the moldingvolume 98 will provide the air containment for the top of the tunnel 98.A slot indicated schematically at 106 is cut out for the travel path ofthe robotic arm 100. This configuration minimizes any contaminantsgenerated from the robot travel or from the channel 102 from enteringthe class 100 air stream in volume 98.

The belt conveyor 74 is preferably supplied with a direct drive (notshown) and plastic cleats (not shown). The conveyor 74 drops offarticles, such as syringe barrels, at a point approximately twelveinches above the level of a packaging station work surface 108. Thepackaging module work surface 108 is raised approximately 13 inches fromthe standard 30 inches to 43 inches above floor level. This dimension isspecified to accommodate the limited vertical travel of the robotic arm100. The inspector 56 and the packager 58 may sit at their respectivestations 52 and 54, and/or may be placed on platforms as necessary, totake the nonstandard work surface height into account.

An accumulator (not shown) is provided at the end of the conveyor 74 toaccommodate irregularities in inspection of packaging cycles.Preferably, two segments of the conveyor (not shown) open directlybeneath the syringe barrels, and will be slightly higher to gently lowerthe syringe barrels onto the accumulator to prevent scuffing the barrelrims. This feature will also permit runners to drop off into a waste binbelow.

As mentioned earlier, the packaging isolation module 14 has a vertical,top-to-bottom laminar airflow, as illustrated in FIG. 4 by the verticalarrows. The work surface panels 108 are constructed of perforatedstainless steel sheeting with approximately 40% open perforated space.This permits the purging of all air from the packaging isolation module14 and contributes to reduced turbulence. It is preferred that the worksurface panels making up the work surface 108 be removable to facilitatecleaning.

FIG. 4 further shows that disposed above respective inspection andpackaging work volumes 110 and 112 is one or more individualself-powered HEPA fan units contained within volume 114. Space 114 alsoincludes lighting fixtures (not shown) to illuminate the work volumes110 and 112. The supply air for the packaging isolation module 14 istaken from the class 100,000 environment at the top and exhausted intothe class 100,000 environment at the bottom.

Inspection station 52 is equipped with a polycarbonate or othertransparent panel 116, for example, commercially available Lexan®, andhas an access slot 118 for the insertion of the inspector's arms andhands. Likewise, the packaging station 54 is equipped with apolycarbonate or other transparent panel 120 which leaves an access slot122 for the insertion of the packager's arms and hands.

FIG. 5a is an isometric view of one embodiment of a packaging isolationmodule 14 of the invention and illustrates the location of access slots118 and 122 which give access to the inspector 56 and packager 58,respectively. Preferably, the overhead fixture 114 includes ion baranti-static assemblies (not shown). FIG. 5b shows a second embodiment ofpackaging isolation module 14 where glove units 119 and 121 areinstalled in access slots 118 and 122. The glove units 119 and 121provide additional isolation for particularly stringent environmentalconditions which require manipulation and access to the packagingisolation module 14 by the inspector 56 and packager 58.

The packaging process can best be understood with reference to FIGS. 2and 6. FIG. 6 is a schematic diagram showing various steps in thepackaging process. In a preferred method, four syringe barrels 126 areinserted into a holder 68a, and four syringe barrels 126 are likewiseinserted into a mating syringe barrel holder 68b. The syringe barrelholders 68a and 68b are assembled into a single clip. As thus assembled,the barrel holders 68a-b and barrels 126 are transferred to thepackaging station 54. The packager 58 inserts two linked clips 68a,bwith eight barrels 126 (together comprising an assembly) into a firstcontainer 128a, such a plastic bag. Optionally, a label may be appliedto the first container 128a. First container 128a, including theassembly, is then placed on the turntable 86, shown in FIG. 2. Afterpackaging a second assembly in a first container 128b, the turntable 86is rotated to align the respective first containers 128a and 128b to theseal bar 88, at such time the respective first containers 128a and 128bare sealed simultaneously. The bag seals are inspected prior to placingand preparing the second container 130, such as a plastic bag. The twobagged assemblies 128a and 128b are pushed into the second container 130which is then pulled back onto the turntable 86. The second container130 is then heat sealed using sealer 88 and the seal is inspected. Theclass 100 packaged barrels are then removed from the enclosure 10 into aless clean environment, preferably at least a class 10,000 environment.Thereafter, the second container 130 is placed inside of a thirdcontainer 132 which is sealed and placed inside a shipping container 134which is closed. A label 136 including shipping or other instructionsmay be applied to shipping container 134.

As shown in FIG. 2, containers 128 and 130 and labels therefor, aredispensed from respective recessed containers 90, 92, and 94 within thepackaging station 54. In a preferred embodiment, containers 128 and 130,and labels therefor, are themselves triple-bagged when received from thesuppliers. The outer two bags for each packaging supply will be removedprior to use. The inner bag for each supply will be removed under thelaminar flow of the packaging isolation module 14. This procedureprevents contaminants from sloughing off the containers and labels ontothe barrels. All packaging supplies are prepared in advance of barrelproduction. Preferably, the end of the barrel holder rail 72 has astainless steel wire spreader (not shown) to facilitate the opening ofthe first and second containers 128 and 130, respectively. Thistechnique for opening the containers will minimize generation ofcontaminant. Any contaminants generated during container opening areknocked down and expelled from the packaging isolation module 14 by thetop-to-bottom laminar airflow in the packaging isolation module 14.

Additional manufacturing modules may be added to the above-mentionedembodiment. These additional modules allow more than one molded articleto be manufactured and assembled in a clean environment. FIG. 7 shows asecond molding isolation module 212 which is coupled between moldingisolation module 12 and packaging isolation module 14. The secondmolding isolation module 212 is similar to the isolation module 12(elements having like numerals on second module 212 being identical tothose on molding isolation module 12). After inspection, articles whichare produced by molding isolation module 12 are placed on conveyer 214and join articles which are produced by second molding isolation module212. These articles are assembled by inspector 216 and placed on barrelholder 70 in the packaging isolation module 14. It is understood thatadditional molding isolation modules may be inserted between secondmolding isolation module 212 and molding isolation module 12 orpackaging isolation module 14 if additional articles are desired.

In an alternative embodiment (not shown), a further an intermediatemodule (not shown) may be inserted in between the inspection station 52and the packaging station 54. This intermediate module may be used forapplying a lubricant, such as silicone oil, to the manufacturedarticles, for example, the inner barrel surfaces of the barrels 126 orother syringe components, such as tip seals (not shown). Furtherintermediate modules 252 may be provided in between the inspectionstation 52 and the packaging station 54 for filling syringes with afluid, such as a contrast medium or drug.

Another further alternative embodiment (not shown) providessterilization for the molded pieces. In this embodiment, the moldingisolation module 12 is sealed from outside air, and air is merelyrecirculated within molding isolation module 12. A sterilizing gas, suchas ozone or ethylene oxide, is added to the interior of the moldingisolation module 12. The sterilization gas sterilizes all the interiorsurfaces within molding isolation module 12 and maintains the sterilitythereof. This embodiment may be used to sterilize molded articles whenthe present invention is used in a manufacturing process which does notinvolve temperatures high enough to render the articles substantiallyfree from contaminants. Alternatively, a vapor phase hydrogen peroxide(VHP) spray which is applied periodically to the interior surfaceswithin molding isolation module 12 may be utilized instead of thesterilizing gas.

While the detailed description has been described in conjunction withsyringe barrels, the process and disclosed apparatus may be used for anymolded components which are desired to remain substantially free fromcontaminants until received and opened by the end user. The inventiontherefore has application to all other kinds of molded containers formedical supplies. Further, the class 100 molding and packaging moduledisclosed above has application to all industrial processes in whichcontaminants are to be minimized, as in semiconductor manufacturingprocesses. By relying on the heat-generating molding step at thebeginning of the procedure, no later autoclaving step is necessary. Theuse of horizontal and vertical laminar airflows keep contaminants fromsettling on the fabricated articles, thereby eliminating thedecontamination step typically requiring washing and drying.

Although the apparatus and manufacturing process of the invention havebeen described in detail for the purpose of illustration, it is to beunderstood that such detail is solely for that purpose and thatvariations can be made thereto by those skilled in the art withoutdeparting from the spirit and scope of the invention except as it may belimited by the claims.

We claim:
 1. A method for manufacturing sterile syringe components, themethod comprising the following steps:providing an enclosure defining asterile environment, the enclosure communicating with an outsideenvironment by means of at least one air filter operable to preventcontaminants from entering the enclosure; providing at least one moldinside the enclosure at a molding station; providing molding materialfrom which to mold the syringe components; heating the molding material;placing the heated molding material within the at least one mold;molding a plurality of one or more syringe components from the moldingmaterial using the at least one mold, the heat generated during one ormore of said heating and molding steps operable to render the moldedsyringe components substantially free from contaminants; forcing airfrom the outside environment through the enclosure through the at leastone air filter to prevent contaminants from adhering to the moldedsyringe components; removing the molded syringe components from the atleast one mold; inspecting the molded syringe components in theenclosure for defects; assembling the molded syringe components in theenclosure to form one or more syringes; filling the one or more syringesin the enclosure with a sterile fluid; and packaging the one or moresyringes in at least one sealed package.
 2. The method of claim 1wherein said enclosure is at least a class 100 environment.
 3. Themethod of claim 1 wherein the enclosure is at least a MCB-3 environment.4. The method of claim 1 wherein said components are molded out ofplastic.
 5. The method of claim 1 and further comprising the step ofintroducing molding material to the mold through a gate in theenclosure.
 6. The method of claim 1 further comprising the stepsof:filtering incoming air flowing into the molding station using said atleast one air filter, and within said molding station, creating ahorizontal laminar airflow through the molding station to preventsettling of any contaminants.
 7. The method of claim 1 furthercomprising the steps of:using a robot disposed within the moldingstation to pick molded components from the mold; using the robot todeposit the components on a conveyor within the enclosure; and conveyingthe components to an inspection station within the enclosure.
 8. Themethod of claim 1 further comprising the steps of:using a mechanical armdisposed within the molding station to pick molded components from themolds; using said mechanical arm to deposit said components on aconveyor within the enclosure; and conveying said components to aninspection station within the enclosure.
 9. The method of claim 1further comprising the steps of:filtering incoming air entering aninspection station within the enclosure using said at least one filter,and creating a vertical laminar airflow in said inspection station toprevent the settling of any contaminants.
 10. The method of claim 1further comprising the steps of:filtering incoming air entering apackaging station within the enclosure using said at least one filter;and creating a vertical laminar airflow in said packaging station toprevent settling of any contaminants.
 11. The method of claim 1 furtherincluding the steps of:providing a sidewall of the enclosure with atransparent panel; and inspecting the components from outside of theenclosure.
 12. The method of claim 11 wherein said step of inspectingincludes inserting hands and arms of an inspector into the enclosurebelow the transparent panel to remove scrap from the components and toreject defective ones of the components.
 13. The method of claim 1wherein said step of packaging includes:providing a sidewall of theenclosure at a packaging station with a transparent panel; and observingsaid step of packaging from outside of the enclosure.
 14. The method ofclaim 13 wherein said step of packaging further includes:inserting handsof a packager into the enclosure below the transparent panel to performa packaging operation.
 15. The method of claim 1 wherein said step ofpackaging includes:enclosing a plurality of the syringes in a firstcontainer; scaling the first container; enclosing the sealed firstcontainer in a second container; and sealing the second container. 16.The method of claim 1 further comprising the steps of:providing aperforated work surface inside the enclosure for said step of packaging;and directing laminar vertical airflow downwardly to pass through theperforations in the work surface.
 17. A method for manufacturing sterilesyringe components, the method comprising the steps of:providing anenclosure containing a sterilizing gas; providing at least one moldinside the enclosure at a molding station; providing molding materialfrom which to mold the syringe components; heating the molding material;placing the heated molding material within the at least one mold;molding a plurality of one or more syringe components from the moldingmaterial using the at least one mold, the heat generated during one ormore of said heating and molding steps operable to render the moldedsyringe components substantially free from contaminants; removing themolded syringe components from the at least one mold; inspecting themolded syringe components in the enclosure for defects; assembling themolded syringe components in the enclosure to form one or more syringes;filling the one or more syringes in the enclosure with a sterile fluid;and packaging the one or more syringes in at least one sealed package.